Tenan Matthew S, Finomore Victor S, Rezai Ali R
Rockefeller Neuroscience Institute, West Virginia University, Morgantown, West Virginia, USA.
Pain Pract. 2025 Jul;25(6):e70058. doi: 10.1111/papr.70058.
Spinal cord stimulation (SCS) is a nonpharmacological, minimally invasive intervention designed to ameliorate chronic low back pain. However, meta-analyses have not supported the use of SCS due to a lack of high-quality evidence. This work provides the necessary information to design better statistically powered clinical trials for SCS by providing estimates and variances for various patient-reported outcomes and biometrics across time in this population.
A cohort of 18 patients was followed across 7 months before and after SCS implantation. The patients were administered a monthly battery of patient-reported outcomes, and daily biometrics were obtained. Multilevel Bayesian distributional models quantified the median and variance change across time, both of which are necessary in sample size calculations. Secondary to estimating effects, we also determine the probability of a directional effect and equivalence.
Scales for pain show sustained improvements and stable variance. There were no changes in quality-of-life medians or variance. Robust improvements were made in fatigue and reported sleep quality, despite an unclear effect on total hours slept as recorded by the daily wearable. Resting heart rate decreased after SCS and had low changes in variance; whereas pulse rate variability/heart rate variability exhibited no median change across time but wild swings in variance, indicating it is a poor biomarker in this population.
This study reports many patient-reported outcomes and digital biomarkers used in SCS clinical research, including which ones have potential value and the exact information necessary to plan future high-quality clinical trials in the SCS population.
There is currently only low-quality evidence that spinal cord stimulation is effective for low back pain. This study supplies all the necessary information (effect estimates, variances and within-measure correlations across time) to better estimate sample sizes, a primary criticism of current evidence in this population. We also provide a preliminary indication as to which patient-reported outcomes and wearable measures are most effective in a spinal cord stimulation population.
脊髓刺激（SCS）是一种非药物、微创的干预措施，旨在缓解慢性腰痛。然而，由于缺乏高质量证据，荟萃分析并不支持使用SCS。本研究通过提供该人群中不同患者报告结局和生物特征随时间变化的估计值和方差，为设计更具统计学效力的SCS临床试验提供了必要信息。
对18名患者在SCS植入前后各7个月进行随访。每月对患者进行一系列患者报告结局的评估，并获取每日生物特征数据。多级贝叶斯分布模型量化了随时间变化的中位数和方差变化，这两者在样本量计算中都是必需的。在估计效应的同时，我们还确定了方向性效应和等效性的概率。
疼痛量表显示持续改善且方差稳定。生活质量的中位数和方差没有变化。疲劳和报告的睡眠质量有显著改善，尽管对日常可穿戴设备记录的总睡眠时间影响不明确。SCS后静息心率下降且方差变化较小；而脉搏率变异性/心率变异性随时间中位数没有变化，但方差波动较大，表明它在该人群中不是一个良好的生物标志物。
本研究报告了SCS临床研究中使用的许多患者报告结局和数字生物标志物，包括哪些具有潜在价值以及规划未来SCS人群高质量临床试验所需的确切信息。
目前仅有低质量证据表明脊髓刺激对腰痛有效。本研究提供了所有必要信息（效应估计值、方差以及随时间的测量内相关性），以便更好地估计样本量，这是当前该人群证据的一个主要缺陷。我们还初步指出了哪些患者报告结局和可穿戴测量在脊髓刺激人群中最有效。
